Clinical Trials

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❘❙❚■ Chapter 35 | Use of TablesSpecific information for fields of tablesAsterisksP-values can sometimes be quoted using asterisks to indicate levels of significance,eg, in a larger table where quoting the P-values themselves would lead to acumbersome table. The normal convention is to use * for P < 0.05, ** for P < 0.01,and *** for P < 0.001, for those values achieving statistical significance [9].Blank cellsAlways fill in blank cells, with zeros if appropriate, or with a note to say why thedata is not available. If you use the abbreviation ‘NA’, state whether this refers to‘not available’ or ‘not applicable’ [8]. If a large number of fields contain zerosor no information, this can be considered a waste of space and you need toconsider restructuring the table or including the information in a different way(eg, combine some rows together).Note on deducing statistical significance fromconfidence intervalsTo deduce significance from a CI on a ‘statistic of comparison’, look to see whetherthe CI contains values that indicate there is no difference between the groups beingcompared. For example, does a 95% CI on an odds ratio, hazard ratio, or relativerisk contain the value 1.0 within the range given? If so, then the results areconsistent with there being no statistically significant difference between the twogroups and we can deduce that P will be greater than 0.05. If the entire 95% CI isabove (or below) 1.0 then there is evidence that there is a significant differencebetween treatment groups with respect to this outcome measure and P will be lessthan 0.05. Similarly, if a 95% CI for an estimated absolute difference in outcomesbetween treatments contains the value 0 (ie, the lower limit is negative and theupper limit is positive) then P > 0.05; otherwise, if the CI contains only positive oronly negative values then P < 0.05 (see Chapter 18).Finally, it is important is to make sure that:• all the key results are contained within the report• written interpretations are consistent with the tables• repetition between tables and text is minimal404
<strong>Clinical</strong> <strong>Trials</strong>: A Practical Guide ■❚❙❘ConclusionTables are an effective way of presenting numeric data concisely, and are usefulfor presenting both the baseline characteristics of patients in each treatmentgroup and the detailed results from a clinical trial. Tables should not be too largeor complex to avoid overwhelming the reader, nor should they be too short, wherethe information might have been better incorporated within a few lines of text.Careful consideration is needed about what tables and figures to incorporatewithin a report and subsequent manuscripts, paying attention to the best way ofpresenting different types of information, as well as the maximum number allowedby journal editors. Tables need to be labeled sensibly, in such a way that the readercan understand the information contained within the table without reference tothe text. Good tables, along with relevant figures (see the next chapter), allow trialconstruction to be clearly understood and results to stand out in a reader’s mind.References1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations forimproving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191–4.2. Day RA. How to Write and Publish a Scientific Paper. Cambridge: Cambridge University Press,1998:61–9.3. Muir KW, Lees KR, Ford I, et al. Magnesium for acute stroke (Intravenous Magnesium Efficacyin Stroke trial): randomised controlled trial. Lancet 2004;363:439–45.4. Villar J, Ba’aqeel H, Piaggio G, et al. WHO antenatal care randomised trial for the evaluationof a new model of routine antenatal care. Lancet 2001;357:1551–64.5. Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression withcompression alone in chronic venous ulceration (ESCHAR study): randomised controlledtrial. Lancet 2004;363:1854–9.6. Huth EJ. Writing and Publishing in Medicine. Philadelphia: Lippincott Williams & Wilkins,1999:139–50.7. Psychology and Psychotherapy: Theory, Research and Practice. Notes for Contributors.Available from: www.bps.org.uk/publications/jHP_6.cfm. Accessed May 5, 2005.8. Wong, I. Editing tables of data. Queensland: Technical editor’s eyrie. Available from:www.jeanweber.com/howto/ed-table.htm. Accessed May 5, 2005.9. Altman DG, Bland JM. Presentation of numerical data. BMJ 1996;312:572.405
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❘❙❚■ ContributorsStephen L
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Clinical Trials: A Practical Guide
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■■❚❙❘Chapter 1RandomizedC
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■■❚❙❘Chapter 4EndpointsAm
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■■❚❙❘Part IIAlternativeTr
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■■❚❙❘Part IIIBasics ofSta
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■■❚❙❘Chapter 17Types of D
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■■❚❙❘Chapter 19Comparison
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■■❚❙❘Chapter 20Comparison
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■■❚❙❘Part IVSpecial Trial
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■■❚❙❘Chapter 24Regression
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■■❚❙❘IndexIndex467
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